Local Study Associate Director

Summary of the group

 To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.

The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Main Duties & Responsibilities

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• • Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
• • Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• • Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• • Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head.
• • Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
• • Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
• • Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
• • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• • Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.
• • Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• • Proactively identifies risks and facilitates resolution of complex study problems and issues.

Education & Experience Requirements:

Minimum Requirements

Bachelor degree in related discipline, preferably in life science and

• Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• • Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.

Required Skills

• • Excellent project management skills.
• • Excellent team building and interpersonal skills.
• • Excellent organisational skills.
• • Excellent verbal and written communication skills.
• • Excellent ability to prioritize and handle multiple tasks.  

• Excellent knowledge of spoken and written English.

The annual base salary for this position ranges from $136,364 - 204,546.00

However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.